1. Field of the Invention
The invention relates to an apparatus in the form of a unit comprising a system with flexible walls, such as containers, bags and tubes, and a sampler for removing samples from the system and for introducing fluids into the systems.
2. Description of the Related Art
One of the current trends in biological processing and pharmaceutical engineering is the increasing use of internally sterile flexible disposal systems. The walls of these systems isolate the inner sterile environment from the outer, largely unsterilized, environment (sterile barrier). When such systems are used, no germs may get from the outside to the inside or from the inside to the outside.
“Sterile system” here is used in the sense that this system is sterile before use and, on account of its design, during use permits no germs to get from the outside into the interior of the system.
One problem when using such systems is the removal of samples from the flexible sterile disposable systems. In the case of blood bags, as the best-known example of sterile, flexible disposable systems, it is known to use a tube that is connected to the sterile interior and closed on the other side, to empty said tube with roller tongs then, with the expansion of the tube after the roller tongs have been removed, to allow the latter to fill with the liquid to be tested, then at the end of the tube to fuse off a piece of tube with two welds located beside each other and to cut through the tube between the welds. The result is a small sample volume in a piece of tube closed securely on both sides. Here, the restriction to very small sample volumes is disadvantageous. Sampling systems such as are used on steel reactors are not known for flexible systems. These have the disadvantage that, for use in conjunction with biological reactors, they are complicated to sterilize, wholly or partly, preferably by means of steam.
The object of the invention is to specify an apparatus for removing samples from systems and for introducing fluids into systems having flexible walls which meets requirements for purity and requires little expenditure for the production and the use of the apparatus.